Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-401-4 | CAS number: 526-95-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- -reliability scoring based on OECD 423 (2001) guideline
- Deviations:
- yes
- Remarks:
- -purity, physico-chemical properties, age, and individual body weight measurements were not provided, 5 animals/sex/group was tested as opposed to 3 animals/group, and other deviations listed in the materials and methods section below
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Potassium gluconate
- EC Number:
- 206-074-2
- EC Name:
- Potassium gluconate
- Cas Number:
- 299-27-4
- IUPAC Name:
- potassium 2,3,4,5,6-pentahydroxyhexanoate (non-preferred name)
- Details on test material:
- - Name of test material (as cited in study report): potassium-gluconate
- Physical state: white-colored crystalline powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute's colony (Central Institute for Nutrition and Food Research)
- Age at study initiation: Young (exact age not reported)
- Weight at study initiation: 240 to 382 (males); 156 to 206 (females)
- Fasting period before study: Before dosing, rats were fasted overnight.
- Housing: Housed in groups of 5 in stainless steel cages
- Diet (e.g. ad libitum): After treatment, the rats received stock diet ad libitum.
- Water (e.g. ad libitum): After treatment, the rats received tap water ad libitum.
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 25
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30% (w/v) aqueous solution
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported
MAXIMUM DOSE VOLUME APPLIED: 20.7 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not reported - Doses:
- 10.0, 12.0, 14.4, 17.3, or 20.7 mL/kg body weight (or 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight)
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examinations of the survivors at autopsy - Statistics:
- Statistical analysis was not performed. LD50 and 95% confidence limits were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6.06 other: g/kg body weight
- 95% CL:
- 5.64 - 6.51
- Remarks on result:
- other: Authors calculated the LD50 value based on mortality-figures
- Mortality:
- The number of male deaths in the 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight groups was 0, 0, 0, 1, and 4 animals, respectively. The number of female deaths in the 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight groups was 0, 0, 0, 1, and 3 animals, respectively. Deaths occurred between 5 and 21 hours after treatment. Afterwards the survivors recovered gradually and looked quite healthy again at the end of the observation period.
- Clinical signs:
- other: Within a few hours after dosing the rats showed sluggishness, humpback behaviour and severe diarrhoea.
- Gross pathology:
- Macroscopic examination of the survivors at autopsy revealed no treatment-related gross alterations.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (EC 1278/2008)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
